Posts Tagged “peg uricase”

Krystexxa comes before the FDA Arthritis Advisory Committee Meeting on Tuesday 16th June.

This is the latest stage to try and get approval for the second new gout drug this year.

Hot on the heals of Uloric, the US brandname for febuxostat, pegloticase (formerly known as PEG-uricase) seeks release under Savient’s brand new name of Krystexxa.

FDA review has been postponed from February to give time for additional analysis of cardiovascular risks.

You can find full details of the meeting, including Savient’s briefing submission on the FDA site.

So what does this mean for gout sufferers?

Assuming approval is given, do not be thinking that you have a newer, easier option for controlling your uric acid.

Krystexxa cannot be taken orally. You get dosed up every two weeks with 8mg delivered by intravenous injection.

As well as being inconvenient, there are fairly high documented reaction rates. On a positve side, it is good that severe gout sufferers have an alternative if they cannot tolerate allopurinol.

So expect plenty drug company stimulated hype over the next few weeks. In fact a gout forum regular has spotted early signs of the latest outbreak of gout hype.

It is such a pity that similar money and exposure does not go into fixing the two great fallacies inherent in healthcare regimes throughout the world:

  1. Gout sufferers need better diagnosis. Too many patients are dismissed without gout because “normal” uric acid range is set too high.
  2. Allopurinol is rarely prescribed properly. Most gout patients do not get the right dose, the right monitoring, or the right support.

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